
Senior Validation Lifecycle Manager
15 hours ago
This pivotal leadership position oversees and manages the validation lifecycle, with a focus on driving continuous improvement initiatives to enhance processes and maintain the highest quality standards.
Main Responsibilities:
- Lead a team in executing technical aspects of validation projects, adhering to predetermined protocols and production requirements.
- Ensure design, installation, and operation of Plant and Equipment are validated in compliance with regulatory requirements.
- Develop strategies to satisfy regulatory bodies' needs, regulations, standards, guidance, and Good Manufacturing Practices (GMP).
- Maintain comprehensive validation policies and procedures.
- Manage a team of Validation Engineers, allocating work, prioritizing tasks, reviewing performance, coaching, training, internal communications, and general personnel assistance.
Necessary Qualifications and Skills:
- Bachelor's degree in a relevant technical field or equivalent.
- A minimum of 5 years high-volume engineering experience in Medical Devices.
- At least 3 years of validation experience.
- Strong working knowledge of statistical techniques, Minitab, Six Sigma, sampling plans/sizes.
- Process development experience, risk analysis/risk management, Failure Mode and Effects Analysis (FMEA), etc.
- Excellent documentation skills.
- Ability to work independently and collaboratively as part of a team.
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